Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FATHOM -16; WIRE, GUIDE, CATHETER
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION FATHOM -16; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 81720
Device Problems Device Contamination with Chemical or Other Material (2944); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2023
Event Type  malfunction  
Event Description
It was reported that device flaking occurred.A 180x25cm fathom -16 guidewire was selected for use.When introducing into the microcatheter, it was noted that some of the coating on the proximal end of the green part of the wire was flaking off.The operator was concerned that the flaking material could create an embolization risk so the device was not inserted into the patient.The device was removed from the microcatheter and the procedure was completed with another bsc fathom wire.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for the analysis, and it is possible to see that the guidewire was kinked at the distal section and the middle section.No more damages were detected.
 
Event Description
It was reported that device flaking occurred.A 180x25cm fathom -16 guidewire was selected for use.When introducing into the microcatheter, it was noted that some of the coating on the proximal end of the green part of the wire was flaking off.The operator was concerned that the flaking material could create an embolization risk so the device was not inserted into the patient.The device was removed from the microcatheter and the procedure was completed with another bsc fathom wire.There were no patient complications reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FATHOM -16
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key17038915
MDR Text Key316336150
Report Number2124215-2023-25312
Device Sequence Number1
Product Code DQX
UDI-Device Identifier08714729762553
UDI-Public08714729762553
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number81720
Device Catalogue Number81720
Device Lot Number0031121660
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
Patient RaceBlack Or African American
-
-